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The objective of the study is to evaluate the effect of consumption of a food supplement rich in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin® consumption on markers involved in the development of hypertension, and endothelial function in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also, try to advance the understanding of the molecular mechanisms that regulate blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product one | Placebo Comparator | 150 mg (maltodextrin)/day (75 mg maltodextrin included in 280 mg/gelule; 2 times/day: morning and evening) of Placebo plus Dietary Approaches to Stop Hypertension (DASH) |
|
| Product two | Active Comparator | 150 mg Oligopin/day (75mg Oligopin included in 280mg/gelule; 2 times/day: morning and evening) of Oligopin® plus Dietary Approaches to Stop Hypertension (DASH) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences detected on the time evolution of BP both in two arms of intervention | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric data (Weight, BMI, Waist circumference) | weeks 2, 5, 6, 9 | |
| Endothelial function (Laser-Doppler) | Weeks 2, 5, 6, 9 | |
| Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa M VALLS, PhD | University Rovira i Virgili | Study Director |
| Rosa SOLÀ, MD,PhD | Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technological Center of Nutrition and Health (CTNS) | Reus | Tarragona | 43204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27765365 | Derived | Valls RM, Llaurado E, Fernandez-Castillejo S, Puiggros F, Sola R, Arola L, Pedret A. Effects of low molecular weight procyanidin rich extract from french maritime pine bark on cardiovascular disease risk factors in stage-1 hypertensive subjects: Randomized, double-blind, crossover, placebo-controlled intervention trial. Phytomedicine. 2016 Nov 15;23(12):1451-1461. doi: 10.1016/j.phymed.2016.08.007. Epub 2016 Aug 23. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C587735 | Oligopin |
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| Oligopin® | Dietary Supplement | Oligopin® PUR' expert (%) is a red brown powder extracted from the bark of the Maritime Pine (Pinus pinaster) with composition: - TOTAL POLYPHENOL CONTENT > 96
PROCYANIDINS CONTENT (GPC) > 67 The Oligopin composition is for 1 gelule: 75 mg Oligopin + 175 mg maltodextrine + 30 mg magnesium stearate: total weight: 280 mg/gelule |
|
| Week 1 |
| - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity) | Weeks 2, 5, 6, 9 |
| - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance) | Weeks 2, 5, 6, 9 |